Medical Device Regulatory and Quality Consultant

Company Description

We believe in the power of ingenuity to build a positive human future. As strategies, technologies, and innovation collide, we create opportunity from complexity. Our diverse teams of experts combine innovative thinking and breakthrough technologies to progress further, faster. Our clients adapt and transform, and together we achieve enduring results. We are over 4,000 strategists, innovators, designers, consultants, digital experts, scientists, engineers, and technologists.

And we have deep expertise in consumer and manufacturing, defence and security, energy and utilities, financial services, government and public services, health and life sciences, and transport. Our teams operate globally from offices across the UK, Ireland, US, Nordics, and Netherlands.

We are seeking a highly skilled consultant with experience in medical device and/or combination product Quality and Regulatory processes to join our Healthcare & Life Sciences (HLS) consulting team. This role focuses on advising clients on the regulatory, Quality and compliance aspects of medical devices, through a strong understanding of regulatory and quality requirements for medical devices, software as a medical device (SaMD), and/or combination products.

The ideal candidate will have experience leading complex technical projects, integrating multidisciplinary expertise, and ensuring regulatory and quality compliance in innovative Med Tech and pharmaceutical product developments.

• Provide expertise on global regulatory requirements for medical devices and combination products ensuring compliance with FDA, EMA, MHRA, MDR/IVDR, and ISO standards.
• Guide processes for hardware, software, and AI-driven medical device development to ensure compliance with applicable regulatory standards and guidance, including ISO 13485, ISO 14971, IEC 62304, and related standards and guidance for AI-driven medical technologies.
• Advise cross-functional teams of designers, mechanical, electrical, software and usability engineers on requirements and best practices for regulatory and quality compliance.
• Ensure requirements traceability from user needs through design, development, verification, and validation.
• Lead risk management activities in accordance with ISO 14971, ensuring safety and efficacy through robust design and process controls.
• Develop and optimise clients’ Quality Management Systems (QMS) to streamline compliance and lifecycle management.

• Work closely with clients’ R&D teams, business stakeholders, and notified bodies to align project goals with industry requirements.
• Facilitate cross-functional collaboration, ensuring smooth integration between engineering, quality, and regulatory disciplines.
• Translate complex technical and regulatory requirements into actionable development strategies for medical technologies.

Flexible working - We are guided by our client work and needs; however, you have autonomy to manage your time and diary to suit your work/life balance.

• The ideal candidate will have:
• A technical background in Engineering (systems, biomedical, mechanical, electrical, software, or related field) or Applied Science (physics, chemistry, biology, materials science, etc.).
• Demonstrated prior direct experience in the design, development, or testing of medical devices and/or combination products.
• At least five years' experience in Med Tech, pharmaceuticals, or life sciences, with a strong track record in regulated product development.
• Deep expertise in regulatory frameworks (FDA, EMA, MDR/IVDR, ISO 13485, IEC 62304, ISO 14971, GAMP, 21 CFR 4/ 820).
• Proven ability to work cross-functionally with engineering, quality, and regulatory teams, contributing practical insights from previous technical roles.
• Strong problem-solving skills, troubleshooting expertise and the ability to drive technical decision-making in a highly regulated environment ensuring alignment with business and regulatory needs.
• Ability to manage multiple concurrent projects.